Patients with confirmed biochemical recurrence of Prostatic Cancer (PCa) after treatment with curative intention. MedDRA version: 20.0 Level: LLT Classification code 10036921 Term: Prostate carcinoma System Organ Class: 100000004864
Conditions
Interventions
Product Name: Fluorocolina (18F)
Product Code: [Fluorocolina (18F)]
Pharmaceutical Form: Solution for injection
INN or Proposed INN: fluorocolina (18F)
Current Sponsor code: fluorocolina (18F)
Other d
Sponsors
ITEL TELECOMUNICAZIONI S.R.L.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Prescription of a PET examination (18F-Fluorocoline or 18F-PSMA) by the oncologist or the urologist, based on the clinical evaluation of the individual patient 2. Histological confirmation of prostate malignancy 3. Patient must have had their primary PCa treated with surgery and/or radiation therapy; salvage radiation to the prostate bed or pelvis is allowed 4. Patient must be = 18 years of age 5. Patient must have an Eastern Cooperative Oncology Group performance status = 2 6. For patients treated with radical prostatectomy: arise of PSA = 0.2 ng/mL (performed in the last month) or a rise of 2 ng/mL or more above the nadir PSA after definitive radiation therapy defined by two subsequent PSA assessments performed over a 3- month period in the same laboratory 7. Absence of any of the exclusion criteria 8. Signed informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Absence of any of the inclusion criteria; 2. More than 3 years of androgen deprivation therapy (ADT), with less than 3 months from the last treatment 3. Spinal cord compression or impending spinal cord compression 4. Receipt of any other investigational agents in the previous 3 months 5. Inability to lie flat during or tolerate PET/CT 6. Hypersensitivity to active substance or any of excipients of Investigational Medicinal Product or Comparator 7. Life expectancy 2 9. Refusal to sign informed consent 10. Participation in a concurrent clinical trial 11. Concomitant active malignancy 12. Subject deprived of its freedom by administrative or legal decision or who is under guardianship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To show in an independent assessment by two readers blinded to clinical data the superiority of 18F-JK-PSMA-7 over 18F-Fluorocholine in patient-based detection rate of recurrent PCa in patients with confirmed biochemical recurrence after treatment with curative intention. Based on available bibliographic data we hypothesize that the detection rate of 18FJKPSMA-7 is at least 20% higher than that of 18F-Fluorocholine;Secondary Objective: • To evaluate the site-based sensitivity and specificity of 18F-JK-PSMA-7 and of 18FFluorocholine PET/CT for recurrent Pca; • To evaluate the frequency of change of actual therapeutic management motivated by result of 18F-JK-PSMA-7 and by 18F-Fluorocholine PET/CT in comparison with initially scheduled therapeutic management; • To evaluate the discordance rate in 18F-JK-PSMA-7 and in 18F-Fluorocholine PET/CT reading among two blinded readers; • To evaluate the safety profile of 18F-JK-PSMA-7 and of 18F-Fluorocholine.;Primary end point(s): The patient-based detection rate of 18F-JK-PSMA-7 and of 18F-Fluorocholine PET/CT as a result of consensus of blind reading using an expert panel as a SOT. The eventual major discordance of results of blind readings will be solved by third reader blinded to results of previous blind readings.;Timepoint(s) of evaluation of this end point: After performing the second PET within 1 month of the first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The site-based sensitivity and specificity of 18F-JK-PSMA-7 and of 18FFluorocholine PET/CT of foci of recurrent Pca; • The change of actual therapeutic management motivated by result of 18F-JK-PSMA- 7 and of 18F-Fluorocholine PET/CT in comparison with initially scheduled therapeutic management; • The discordance rate in 18F-JK-PSMA-7 and in 18F-Fluorocholine PET/CT reading among two blinded readers; • The adverse events or reactions related with use of 18F-JK-PSMA-7 and with use of 18F-fluorocholine.;Timepoint(s) of evaluation of this end point: After performing the second PET within 1 month of the first. | — |
Countries
Italy
Contacts
Public ContactQualified Person
ANNA TOLOMEO
Outcome results
None listed